Advanced Pancreatic Ductal AdenocarcinomaPhase 2NCT06825546
Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing Icaritin and AG chemotherapy in people with Advanced Pancreatic Ductal Adenocarcinoma, run by Sir Run Run Shaw Hospital at 6 sites in China.
Trial summary
Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Icaritin and AG chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2025to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old (including the cutoff value).
- patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) disease from multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (group lead unit).
- locally advanced or metastatic PDAC according to the 2024 CSCO Guidelines for the Management of Pancreatic Cancer.
- no prior systemic therapy.
- presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Eastern Cooperative Oncology Group PS 0 or 1.
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- have a life expectancy of at least 3 months.
- adequate organ function (absolute neutrophil count ≥1.5×109/L; Platelet count ≥100×109/L; Creatinine <1.5×ULN (upper limit of normal) or creatinine clearance (CRCI) ≥60 ml/min; Albumin ≥30g/L; Total bilirubin <5×ULN; Aspartate aminotransferase (AST) <2.5×ULN; Alanine aminotransferase (ALT) <2.5×ULN (≤5×ULN is acceptable if liver metastasis is present); INR or PT < 1.5×ULN, APTT < 1.5×ULN.
- in a fertile woman, a negative serum pregnancy test within 7 days before the first trial treatment;
- willingness to use a highly effective contraceptive method (failure rate < 1.0% per year) from the first study treatment until 24 weeks after completion of the trial treatment, if the woman is fertile or the male participant's partner is fertile.
- no other serious underlying medical conditions.
- voluntarily participated in this study and signed informed consent. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent.
Who cannot join
- neuroendocrine (carcinoid, islet cell) or pancreatic acinar carcinoma.
- Patients had moderate to severe ascites (ascites was defined by B-ultrasound).
- untreated active central nervous system or meningeal metastases.
- Previous systemic therapies such as targeted therapy, immunotherapy, chemotherapy, and modern Chinese medicine with anti-tumor indications or other treatments such as surgery and particle implantation have been used to treat pancreatic cancer.
- surgery for any reason (other than diagnostic biopsy), within 4 weeks after the first trial treatment, and/or the subject did not fully recover from surgery within 4 weeks after the first trial treatment.
- history of RT within 3 months of the first dose of trial treatment. No more than 30% bone marrow irradiation or large field irradiation should be used in the 4 weeks before the first trial treatment.
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- patients with a history of other cancers within the past 2 years.
- major cardiovascular impairment in the 12 months before the first dose of study drug: such as a history of congestive heart failure higher than NYHA class II, unstable angina, myocardial infarction, or stroke due to cerebrovascular accident, or arrhythmia associated with hemodynamic instability; The corrected QT (QTc) interval was prolonged >480ms.
- with bleeding or thrombotic diseases or receiving thrombolytic therapy, and coagulopathy; Patients who were deemed by the investigator to be ineligible for participation in the study.
- clinically significant hemoptysis or tumor bleeding of any cause within 2 weeks before the first dose of study intervention.
- patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric illness, or hypertension The investigator will determine whether clinical severity prevents informed consent from being signed or affects patient adherence to oral medication.
- had active autoimmune disease requiring systemic therapy within the previous 2 years.
- may have other comorbidities that are relatively contraindicated in this trial.
- had a severe allergic reaction to the active ingredient of the trial drug.
- were pregnant or lactating, or were unwilling to plan pregnancy during the trial.
- any other medical condition that the investigator considered to interfere with the requirements of the trial in terms of safety or efficacy assessment or adherence to treatment.
- vulnerable groups except the elderly/illiterate, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410021
Yi Liu, +8613077383585, Liuyi0802@hunnu.edu.cn
- Not yet recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Zhiqiang Fu, +8615113812759, 496763865@gq.com
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Xiaolong Liu, +86 13588457667, liuxiaolong@zju.edu.cn
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yunfeng Shan, +8613857763998, 13808807@qq.com
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Dongde Wu, +8615629019627, 971070316@qq.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Tao Qin, +861394916088
About this study
Official title: A Multicenter Study Assessing the Efficacy and Safety of Icaritin in Combination With AG Chemotherapy Versus AG Chemotherapy Alone in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus,we investigated the efficacy and safety of Icaritin administered in conjunction with AG in patients newly diagnosed with advanced pancreatic ductal adenocarcinoma, compare with AG only.
Read the detailed description
This study aims to evaluate the superiority of Icaritin soft capsules combined with the AG chemotherapy regimen (including gemcitabine) compared to the AG regimen alone. By modulating the immune microenvironment, the combined therapy is expected to provide synergistic enhancement. This will lay the groundwork and provide data for subsequent large-scale randomized controlled clinical trials, ultimately offering more effective combination therapies for patients with advanced pancreatic cancer and improving survival outcomes.
- Being tested
- Icaritin, AG chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcaritinDrug
Icaritin soft capsules, 600 mg, taken twice daily, should be swallowed with warm water within 30 minutes after breakfast and dinner. If a patient misses a dose and cannot take it within 2 hours after a meal, they should continue with the next scheduled dose without needing to make up for the missed dose.
Gemcitabine, 1000 mg/m², is administered on days 1 and 8, followed by a 14-day pause, constituting a 21-day treatment cycle. Nab-paclitaxel, 125 mg/m², is also administered on days 1 and 8, with a 14-day pause, making up a 21-day treatment cycle.
AG chemotherapyDrug
Gemcitabine (1000 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush.
Nab-paclitaxel (125 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush
| Study group | Role | What they receive |
|---|---|---|
| Icaritin + AG chemotherapy | Experimental | Icaritin soft capsules, 600 mg, taken twice daily, should be swallowed with warm water within 30 minutes after breakfast and dinner. If a patient misses a dose and cannot take it within 2 hours after a meal, they should continue with the next scheduled dose without needing to make up for the missed dose.
Gemcitabine, 1000 mg/m², is administered on days 1 and 8, followed by a 14-day pause, constituting a 21-day treatment cycle. Nab-paclitaxel, 125 mg/m², is also administered on days 1 and 8, with a 14-day pause, making up a 21-day treatment cycle. Receives: Drug: Icaritin; Drug: AG chemotherapy |
| AG chemotherapy | Active comparator | 1. Gemcitabine (1000 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush.
2. Nab-paclitaxel (125 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush Receives: Drug: AG chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The proportion of patients with optimal response achieving complete or partial response
Measured: 2 years
Secondary outcomes (2)
PFS
If the patient has not progressed or died at the last follow-up, the date on which the clinician last confirmed that there was no tumor progression will prevail. For patients who are lost to follow-up, the date when the tumor was last recorded as not progressing will be considered. Patients who have started a new treatment prior to progression will have the date their tumor was last recorded prior to the new treatment.
Measured: 2 years
OS
If the patient is still alive at the last follow-up, the date of the clinician's last confirmation of the patient's survival shall prevail. For patients who were lost to follow-up, the date of last recorded patient survival was considered.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825546
- Sponsor's protocol ID
- 20240721
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Assessing the Efficacy and Safety of Icaritin in Combination With AG Chemotherapy Versus AG Chemotherapy Alone in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06825546
- Acronym / sponsor ID
- 20240721
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus,we investigated the efficacy and safety of Icaritin administered in conjunction with AG in patients newly diagnosed with advanced pancreatic ductal adenocarcinoma, compare with AG only.
Detailed description
This study aims to evaluate the superiority of Icaritin soft capsules combined with the AG chemotherapy regimen (including gemcitabine) compared to the AG regimen alone. By modulating the immune microenvironment, the combined therapy is expected to provide synergistic enhancement. This will lay the groundwork and provide data for subsequent large-scale randomized controlled clinical trials, ultimately offering more effective combination therapies for patients with advanced pancreatic cancer and improving survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icaritin + AG chemotherapy | Experimental | Drug: Icaritin, Drug: AG chemotherapyIcaritin soft capsules, 600 mg, taken twice daily, should be swallowed with warm water within 30 minutes after breakfast and dinner. If a patient misses a dose and cannot take it within 2 hours after a meal, they should continue with the next scheduled dose without needing to make up for the missed dose. Gemcitabine, 1000 mg/m², is administered on days 1 and 8, followed by a 14-day pause, constituting a 21-day treatment cycle. Nab-paclitaxel, 125 mg/m², is also administered on days 1 and 8, with a 14-day pause, making up a 21-day treatment cycle. |
| AG chemotherapy | Active comparator | Drug: AG chemotherapy1. Gemcitabine (1000 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush. 2. Nab-paclitaxel (125 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-80 years old (including the cutoff value).
- patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) disease from multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (group lead unit).
- locally advanced or metastatic PDAC according to the 2024 CSCO Guidelines for the Management of Pancreatic Cancer.
- no prior systemic therapy.
- presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Key exclusion criteria (17 listed)
- neuroendocrine (carcinoid, islet cell) or pancreatic acinar carcinoma.
- Patients had moderate to severe ascites (ascites was defined by B-ultrasound).
- untreated active central nervous system or meningeal metastases.
- Previous systemic therapies such as targeted therapy, immunotherapy, chemotherapy, and modern Chinese medicine with anti-tumor indications or other treatments such as surgery and particle implantation have been used to treat pancreatic cancer.
- surgery for any reason (other than diagnostic biopsy), within 4 weeks after the first trial treatment, and/or the subject did not fully recover from surgery within 4 weeks after the first trial treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IcaritinIcaritin soft capsules, 600 mg, taken twice daily, should be swallowed with warm water within 30 minutes after breakfast and dinner. If a patient misses a dose and cannot take it within 2 hours after a meal, they should continue with the next scheduled dose without needing to make up for the missed dose. Gemcitabine, 1000 mg/m², is administered on days 1 and 8, followed by a 14-day pause, constituting a 21-day treatment cycle. Nab-paclitaxel, 125 mg/m², is also administered on days 1 and 8, with a 14-day pause, making up a 21-day treatment cycle. | Drug | Icaritin + AG chemotherapy |
| AG chemotherapyGemcitabine (1000 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush. Nab-paclitaxel (125 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush | Drug | AG chemotherapy, Icaritin + AG chemotherapy |
Primary outcome
ORR
Time frame: 2 years
The proportion of patients with optimal response achieving complete or partial response
2 secondary outcomes
PFS
Time frame: 2 years
OS
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icaritin and AG chemotherapy in people with Advanced Pancreatic Ductal Adenocarcinoma, run by Sir Run Run Shaw Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Liu (13588457667, liuxiaolong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.